Medicare Part D spending · FDA facts · help paying
Varenicline Tartrate: what Medicare Part D spends and the dated federal facts we hold
CMS's Medicare Part D spending dataset reports gross spending on Varenicline Tartrate of $132.50 million in 2024, across 569,550 claims and 227,836 beneficiaries. 1 non-manufacturing label change is dated in the last 12 months in the FDA's file. The FDA's enforcement reports name this drug's packages in 1 recall entry.
Medicare Part D spending
CMS's Medicare Part D spending dataset reports gross spending on Varenicline Tartrate of $132.50 million in 2024, across 569,550 claims and 227,836 beneficiaries. CMS's dataset states spending is gross drug cost and does not reflect manufacturers' rebates or other price concessions. Spending is the total paid by Medicare, plans and beneficiaries for the drug's claims, not what a patient pays.
| Year | Gross spending | Claims | Beneficiaries | Average spending per claim |
|---|---|---|---|---|
| 2024 | $132.50 million | 569,550 | 227,836 | $233 |
| 2023 | $189.56 million | 490,761 | 197,586 | $386 |
| 2022 | $151.26 million | 365,626 | 144,102 | $414 |
| 2021 | $33.30 million | 76,472 | 39,738 | $436 |
Source: CMS Medicare Part D spending by drug (data-year-2024, modified 2026-06-25), read November 7, 2026. CMS dataset page. All manufacturers combined; the figures are a drug-level aggregate of claims and say nothing about a formulary or coverage.
Medicaid use by state
CMS's State Drug Utilization Data records, for 2025, how many prescriptions each state's Medicaid program paid for under this drug's packages and what it reimbursed. The 10 states with the largest reimbursement are shown of 45 with data. Reimbursement is before the rebates manufacturers pay states, so it is not a net cost and not a price a patient pays.
| State | Medicaid-paid prescriptions | Medicaid reimbursed | Covers |
|---|---|---|---|
| TX | 2,698 | $332,473 | Fee-for-service only |
| MI | 2,826 | $179,927 | Fee-for-service only |
| PA | 1,783 | $144,781 | Fee-for-service only |
| LA | 2,029 | $140,759 | Fee-for-service only |
| NY | 3,347 | $134,617 | Fee-for-service only |
| OH | 3,614 | $134,049 | Fee-for-service only |
| CA | 2,647 | $113,030 | Fee-for-service only |
| IN | 1,075 | $102,631 | Fee-for-service only |
| NC | 1,999 | $82,349 | Fee-for-service only |
| VA | 616 | $78,069 | Fee-for-service only |
Where the publisher suppresses small managed-care cells, a state's figure covers fee-for-service claims only and understates use (63 state and package figures are marked that way here). A state missing from the table means its figures were suppressed or not reported, not zero use. 153 older-year figures are held and left out of the table.
Source: CMS State Drug Utilization Data (State Drug Utilization Data 2025, modified 2026-07-13T15:28:32Z), read November 7, 2026. CMS dataset page. State-reported data compiled by CMS; aggregate by state and package, no provider or patient data.
Medicaid spending
CMS's Medicaid spending dataset reports $56.37 million for Varenicline Tartrate in 2024. CMS's dataset states spending includes Federal and State reimbursement and dispensing fees and is not reduced by Medicaid rebates paid to the states. Spending is what Medicaid paid, not what a patient pays.
| Year | Spending | Claims |
|---|---|---|
| 2024 | $56.37 million | 425,108 |
| 2023 | $128.35 million | 421,198 |
| 2022 | $96.21 million | 298,442 |
| 2021 | $11.20 million | 31,726 |
Source: CMS Medicaid spending by drug (data-year-2024, modified 2026-06-25), read November 7, 2026. CMS dataset page. A national drug-level aggregate; it says nothing about any state's coverage rules.
Where help paying exists
No program in our finder currently lists this drug as open to new patients.
Label changes
FDA actions on the applications behind Varenicline Tartrate dated since November 11, 2025, leaving out manufacturing (CMC) changes. 1 change in the window.
| Date | Class | Application | Submissions | FDA documents |
|---|---|---|---|---|
| December 18, 2025 | Labeling | ANDA211862 | 4 | No document linked in the FDA file |
Source: FDA Drugs@FDA data file, read November 7, 2026. Dates are the FDA action dates; the documents are on FDA's own site. FDA data file. All recent changes across these drugs: label changes feed.
Safety notices
FDA enforcement report entries that name a package of Varenicline Tartrate by its NDC: 1 entry, newest first. FDA assigns each a class by health risk: Class I is the most serious and Class III the least. An entry records what the recalling firm reported and FDA classified; it is not advice about any package you hold.
| Reported | Class | Status | Recalling firm | Reason (shortened) | Packages named |
|---|---|---|---|---|---|
| December 17, 2025D-0219-2026 | Class III | Ongoing | Dr. Reddy's Laboratories, Inc. | Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit. | 4 |
Source: openFDA drug enforcement reports, file read November 7, 2026. openFDA data file. All recent recalls across these drugs: drug recalls feed.
Questions
Does Medicare have a negotiated price for Varenicline Tartrate?
The CMS negotiated-price file we read does not list Varenicline Tartrate, so this page shows no negotiated price. A drug appears in that file only when CMS selects it for negotiation, and not being listed says nothing about what it costs a patient.
Is there help paying for Varenicline Tartrate?
No program in our finder lists this drug yet.
How much does Medicare Part D spend on Varenicline Tartrate?
CMS's Medicare Part D spending dataset reports gross spending on Varenicline Tartrate of $132.50 million in 2024, across 569,550 claims and 227,836 beneficiaries. CMS's dataset states spending is gross drug cost and does not reflect manufacturers' rebates or other price concessions. Spending is the total paid by Medicare, plans and beneficiaries for the drug's claims, not what a patient pays.
For developers: this drug as data
One call returns the generic-entry upper bound, label history, recalls, trials, assistance and Part D spending, and where facts exist the FDA safety program (REMS), DEA schedule, orphan designations, safety notices and Medicaid use by state, each with receipts.
Example file: https://omnirx.org/api/v1/dossier/varenicline-tartrate.json
The licence page sets out what a data licence covers, and the API page documents these files.
Evaluation files with receipts; contract may change; not clinical advice.
Sources and terms. This drug is not in the CMS negotiated-price file, so no price source is used. Program details read from each program's own pages; CMS Medicare Part D spending by drug; CMS Medicaid spending by drug; FDA Drugs@FDA and Orange Book data files; openFDA drug enforcement reports. Figures are stored with their sources in the OmniRx library (edition 2026-11). Free to cite with attribution. Not medical, legal or financial advice. Report an error through the contact page. Licence the data.